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CompletedNCT00691171Updated Apr 15, 2015

Electronic Health Record (EHR)-Based Intervention for Gastroesophageal Reflux Disease (GERD) and Chronic Non-steroidal Anti-inflammatory Drug (NSAID) Use

An observational study in GERD, sponsored by AstraZeneca. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-15.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
5,234
Ages
18 Years and older
Sex
All
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Study summary

The purpose of the study is to examine the impact of augmented, high-quality physician-coordinated care executed via an electronic health record (EHR)-based intervention on quality of care for gastroesophageal reflux disease (GERD) and for gastroprotection for patients on chronic non-steroidal anti-inflammatory drugs (NSAIDs) at increased risk for upper GI tract ulcers and ulcer related complications.

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Conditions studied

  • GERD

Keywords

  • gastroesophageal reflux disease
  • GERD
  • nonsteroidal anti-inflammatory drugs
  • peptic ulcer
  • Diagnosed GERD
  • Atypical GERD symptoms
  • chronic NSAID therapy
  • Risk for ulcer
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In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 5,234 is above the median of 180 across 298 observational studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primarily primary care practices of physicians participating in the Medical Quality Improvement Consortium (MQIC)

Inclusion criteria

  • Eligibility as determined by criteria for participation in studies as part of the MQIC
  • Agreement of participating clinical practices to undergo training in the electronic health record (EHR) intervention designed for this study

Exclusion criteria

Exclusion Criteria:

  • Based on voluntary participation by MQIC practices, so practices were excluded if they decided to opt out
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
5,234 participants (actual)

Groups and cohorts

  • 1

    GERD: Patients with established diagnoses of GERD based on ICD-9 codes

  • 2

    Atypical GERD: Patients without an established diagnosis of GERD with atypical symptoms that could be due to GERD (e.g., asthma)

  • 3

    Chronic NSAID users: Patients using chronic NSAIDs who are at increased risk of GI complications (defined as previous diagnosis of peptic ulcer disease; age 75 or older; or concomitant use of corticosteroids, anticoagulants, or aspirin)

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What researchers measure

Primary outcomes

  1. Diagnoses of GERD

    Time frame: After 12 months of intervention

  2. Prescriptions for gastroprotective medicines in at-risk, chronic NSAID users

    Time frame: After 12 months of intervention

Secondary outcomes

  1. Prescriptions for GERD medications

    Time frame: After 12 months of intervention

  2. Change in GERD symptoms score

    Time frame: After 12 months of intervention

  3. NSAID-related GI complications

    Time frame: After 12 months of intervention

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Gill JM, Mainous AG 3rd, Koopman RJ, Player MS, Everett CJ, Chen YX, Diamond JJ, Lieberman MI. Impact of EHR-based clinical decision support on adherence to guidelines for patients on NSAIDs: a randomized controlled trial. Ann Fam Med. 2011 Jan-Feb;9(1):22-30. doi: 10.1370/afm.1172. PubMed 21242557 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00691171
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jun 5, 2008
Start date
Jan 2007
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Apr 15, 2015

Study contacts

James M Gill, MD, PhD
principal investigator · Delaware Valley Outcomes Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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